Pregnancy Complicated With Intrauterine AdhesionNCT07883057
Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions
An observational study of Pregnancy Complicated With Intrauterine Adhesion, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial summary
In cases of early pregnancy complicated with intrauterine adhesions (IUAs), termination of pregnancy is prone to incomplete abortion with retained gestational products, failed abortion or uterine perforation due to altered uterine cavity structure and gestational sac obscured by adhesive bands. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Pregnancy Complicated With Intrauterine Adhesion
- What is being tested?
- Vacuum Aspiration Group and Hysteroscopy adhesiolysis combined with vacuum aspiration
- Type of treatment
- Surgery or procedure
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Dec 2026to Aug 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Female patients aged 18-40 years diagnosed with intrauterine adhesions and early intrauterine pregnancy who voluntarily receive abortion surgery in our hospital. Patients with molar pregnancy, incomplete follow-up data and surgery performed outside our hospital are excluded.
Who may be able to join
- patients with transvaginal ultrasound findings suggestive of IUA;
- patients who underwent follow-up postoperative ultrasound examinations for 3 or more months at the study hospital;
- patients with a desire to bear children;
- patients with no significant organic diseases.
Who cannot join
- patients with ectopic pregnancies, e.g., a cesarean scar pregnancy, angular pregnancies, or a cervical pregnancy;
- patients who underwent other intrauterine surgical procedures, such as endometrial polypectomy, submucosal myomectomy, or uterine septum resection, during hysteroscopy;
- patients who underwent medical termination of pregnancy with oral mifepristone plus misoprostol without surgery;
- patients with abnormal postoperative pathological results, e.g., molar pregnancy;
- patients without follow-up data or ultrasound results or with incomplete data for 3 months after surgery;
- patients whose initial surgery was not performed at the study hospital.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Women's Hospital, Zhejiang University School of Medicine
Hangzhou
Jiang Xiuxiu, +86 15167147558, 5515036@zju.edu.cn
About this study
Official title: Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions: A Prospective Observational Study
In cases of early pregnancy complicated with intrauterine adhesions (IUAs), termination of pregnancy is prone to incomplete abortion with retained gestational products, failed abortion or uterine perforation due to altered uterine cavity structure and gestational sac obscured by adhesive bands. Reoperation may even be required, which increases the risk of surgical trauma, as well as the psychological and financial burdens on patients. Meanwhile, some patients with IUAs still have fertility demands in the future, so the adhesions also need to be addressed.
Hysteroscopy allows direct visualization to remove intrauterine gestational contents, lowering the risks of tissue retention and reoperation. It also enables concurrent treatment of existing IUAs. Combined with postoperative interventions to prevent adhesion recurrence, this approach can restore the uterine cavity structure and endometrium, improve subsequent fertility, and reduce patients' psychological stress as well as the time and economic costs incurred by repeated hospital admissions and surgeries for IUAs.
Read more
This clinical controlled study aims to explore the clinical outcomes and advantages of hysteroscopy applied for termination of early pregnancy combined with simultaneous management of IUAs, so as to provide reliable evidence for the clinical application of combined hysteroscopic abortion and adhesiolysis in such patients. In addition, immunohistochemical detection of decidual tissues will be performed to analyze the influences of immune cell subsets, inflammatory markers, vascular remodeling-related markers and other indicators on the disease, offering references for its clinical management and treatment.
This is a prospective controlled study. Eligible patients diagnosed with early pregnancy complicated with IUAs who underwent pregnancy termination in the Family Planning Ward of our hospital will be enrolled from the date of ethical approval in accordance with the inclusion and exclusion criteria. Patients are divided into two groups: the experimental group receives hysteroscopic abortion combined with simultaneous adhesiolysis, and the control group undergoes ultrasound-guided artificial abortion.
After being fully informed of the pros and cons of both surgical procedures, patients will select their preferred operation voluntarily. General patient information will be recorded, including age, obstetric history, fetal viability of the current pregnancy, intraoperative blood loss, placement of anti-adhesive materials in the uterine cavity and postoperative estrogen administration. Postoperative follow-up will be conducted for 2 years after the enrollment of the last subject, with observed indicators including the rate of residual gestational tissue, recurrence rate of IUAs and subsequent pregnancy outcomes.
Appropriate statistical descriptive indicators and analytical methods will be selected based on the research objectives, data types and distribution characteristics. Statistical differences and clinical implications between the two surgical protocols will be compared and analyzed
- Being tested
- Vacuum Aspiration Group, Hysteroscopy adhesiolysis combined with vacuum aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vacuum Aspiration GroupProcedure or surgery
Vacuum Aspiration Group: Negative pressure aspiration was performed using a rigid vacuum cannula
Hysteroscopy adhesiolysis combined with vacuum aspirationProcedure or surgery
Hysteroscopic intrauterine adhesiolysis is performed to separate adhesions, after vacuum aspiration for early pregnancy termination.
| Study group | Role | What they receive |
|---|---|---|
| Vacuum Aspiration Group | Not described Receives: Procedure: Vacuum Aspiration Group | |
| Hysteroscopy Group | Not described Receives: Procedure: Hysteroscopy adhesiolysis combined with vacuum aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of subsequent pregnancy after surgery
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy Complicated With Intrauterine AdhesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883057
- Sponsor's protocol ID
- IRB-20250474-R
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07883057
- Acronym / sponsor ID
- IRB-20250474-R
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In cases of early pregnancy complicated with intrauterine adhesions (IUAs), termination of pregnancy is prone to incomplete abortion with retained gestational products, failed abortion or uterine perforation due to altered uterine cavity structure and gestational sac obscured by adhesive bands. Reoperation may even be required, which increases the risk of surgical trauma, as well as the psychological and financial burdens on patients. Meanwhile, some patients with IUAs still have fertility demands in the future, so the adhesions also need to be addressed.
Hysteroscopy allows direct visualization to remove intrauterine gestational contents, lowering the risks of tissue retention and reoperation. It also enables concurrent treatment of existing IUAs. Combined with postoperative interventions to prevent adhesion recurrence, this approach can restore the uterine cavity structure and endometrium, improve subsequent fertility, and reduce patients' psychological stress as well as the time and economic costs incurred by repeated hospital admissions and surgeries for IUAs.
This clinical controlled study aims to explore the clinical outcomes and advantages of hysteroscopy applied for termination of early pregnancy combined with simultaneous management of IUAs, so as to provide reliable evidence for the clinical application of combined hysteroscopic abortion and adhesiolysis in such patients. In addition, immunohistochemical detection of decidual tissues will be performed to analyze the influences of immune cell subsets, inflammatory markers, vascular remodeling-related markers and other indicators on the disease, offering references for its clinical management and treatment.
This is a prospective controlled study. Eligible patients diagnosed with early pregnancy complicated with IUAs who underwent pregnancy termination in the Family Planning Ward of our hospital will be enrolled from the date of ethical approval in accordance with the inclusion and exclusion criteria. Patients are divided into two groups: the experimental group receives hysteroscopic abortion combined with simultaneous adhesiolysis, and the control group undergoes ultrasound-guided artificial abortion.
After being fully informed of the pros and cons of both surgical procedures, patients will select their preferred operation voluntarily. General patient information will be recorded, including age, obstetric history, fetal viability of the current pregnancy, intraoperative blood loss, placement of anti-adhesive materials in the uterine cavity and postoperative estrogen administration. Postoperative follow-up will be conducted for 2 years after the enrollment of the last subject, with observed indicators including the rate of residual gestational tissue, recurrence rate of IUAs and subsequent pregnancy outcomes.
Appropriate statistical descriptive indicators and analytical methods will be selected based on the research objectives, data types and distribution characteristics. Statistical differences and clinical implications between the two surgical protocols will be compared and analyzed
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vacuum Aspiration Group | – | Procedure: Vacuum Aspiration Group |
| Hysteroscopy Group | – | Procedure: Hysteroscopy adhesiolysis combined with vacuum aspiration |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female patients aged 18-40 years diagnosed with intrauterine adhesions and early intrauterine pregnancy who voluntarily receive abortion surgery in our hospital. Patients with molar pregnancy, incomplete follow-up data and surgery performed outside our hospital are excluded.
Key inclusion criteria (4 listed)
- patients with transvaginal ultrasound findings suggestive of IUA;
- patients who underwent follow-up postoperative ultrasound examinations for 3 or more months at the study hospital;
- patients with a desire to bear children;
- patients with no significant organic diseases.
Key exclusion criteria (6 listed)
- patients with ectopic pregnancies, e.g., a cesarean scar pregnancy, angular pregnancies, or a cervical pregnancy;
- patients who underwent other intrauterine surgical procedures, such as endometrial polypectomy, submucosal myomectomy, or uterine septum resection, during hysteroscopy;
- patients who underwent medical termination of pregnancy with oral mifepristone plus misoprostol without surgery;
- patients with abnormal postoperative pathological results, e.g., molar pregnancy;
- patients without follow-up data or ultrasound results or with incomplete data for 3 months after surgery;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vacuum Aspiration GroupVacuum Aspiration Group: Negative pressure aspiration was performed using a rigid vacuum cannula | Procedure or surgery | Vacuum Aspiration Group |
| Hysteroscopy adhesiolysis combined with vacuum aspirationHysteroscopic intrauterine adhesiolysis is performed to separate adhesions, after vacuum aspiration for early pregnancy termination. | Procedure or surgery | Hysteroscopy Group |
Primary outcome
Rate of subsequent pregnancy after surgery
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Complicated With Intrauterine Adhesion, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiang Xiuxiu (+86 15167147558, 5515036@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of subsequent pregnancy after surgery (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.